PlainRecalls

Datascope Corporation

Compiled from official public sources by the publisher.

67 recalls on record · Latest: Nov 2, 2022

Subscribe to new Datascope Corporation recalls (RSS)

Agency notice ledger

Federal filing book Datascope Corporation MID-BOOK · SINGLE-AGENCY

#269 of 14,151 · 67 notices · 0.064% archive

  • BOOK 67 notices
  • RANK #269 of 14,151
  • SHARE 0.064% archive
  • AGENCY FDA Devices (67)
  • CAT medical devices
  • CATS 1 category
  • LATEST Nov 2, 2022
  • PHOTO Kroger Specialty Phar…

Nearest notice-volume peer: Kroger Specialty Pharmacy, Inc. (0 notice gap)

Datascope Corporation accounts for about 0.064% of the 104,423-notice archive on 67 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Datascope Corporation's standing among 14,151 recalling firms

Datascope Corporation ranks 269th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Datascope Corporation vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

67 269th of 14151 higher than 13,881 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Datascope Corporation in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Datascope Corporation holds about 0.064% of archive notices alongside 67 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Nov 2, 2022

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
FDA Devices Moderate Sep 14, 2022

MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
FDA Devices Moderate Sep 14, 2022

Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
FDA Devices Moderate Sep 14, 2022

Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
FDA Devices Moderate Sep 2, 2020

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
FDA Devices Moderate Feb 12, 2020

Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
FDA Devices Moderate Feb 12, 2020

Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
FDA Devices Moderate Feb 12, 2020

Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
FDA Devices Moderate Jul 24, 2019

Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscl
FDA Devices Moderate Jun 20, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to s
FDA Devices Moderate Jun 20, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for u
FDA Devices Moderate Jun 20, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up t
FDA Devices Low Jun 13, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
FDA Devices Low Jun 13, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
FDA Devices Low Jun 13, 2018

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
FDA Devices Moderate May 16, 2018

BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
FDA Devices Moderate May 16, 2018

BEQ-TOP 22300, Custom Tubing Kit, Catalog No. 701049504
FDA Devices Moderate May 16, 2018

BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
FDA Devices Moderate May 16, 2018

BEQ-TOP 22301, Custom Tubing Kit, Catalog No. 701049513
FDA Devices Moderate May 16, 2018

BEQ-TOP 33700 ECC 3/8" PACK, Custom Tubing Pack with Bioline Coating, Catalog No. 701053845
FDA Devices Moderate May 16, 2018

Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
FDA Devices Moderate May 16, 2018

BO-TOP 13901 RAPID RESPONSE, Custom Tubing Kit, Catalog No. 701054874
FDA Devices Moderate May 16, 2018

ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
FDA Devices Moderate May 16, 2018

BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
FDA Devices Moderate May 16, 2018

BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
FDA Devices Moderate May 16, 2018

BEQ-TOP 22701, Catalog No. 701050790
FDA Devices Moderate May 16, 2018

BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368
FDA Devices Moderate May 16, 2018

BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434
FDA Devices Moderate May 16, 2018

BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
FDA Devices Moderate May 16, 2018

NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01
FDA Devices Moderate May 16, 2018

BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486
FDA Devices Moderate May 16, 2018

BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867
FDA Devices Moderate May 16, 2018

BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
FDA Devices Moderate May 16, 2018

BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430

Datascope Corporation carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Microbiologics Inc 66 Nobel Biocare Usa Llc 66 Philips Medical Systems, Inc. 65 Stryker Sustainability Solutions 65

Frequently Asked Questions

How many federal recall notices name Datascope Corporation? ▼
PlainRecalls indexes 67 distinct federal recall events naming Datascope Corporation, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Datascope Corporation sit among other recalling firms? ▼
Datascope Corporation ranks #269 of 14,151 by distinct recall-event count among 14,151 firms in this archive (98th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Datascope Corporation's notices? ▼
FDA Devices accounts for 67 of this firm's 67 indexed notices.
What product category dominates Datascope Corporation's filing book? ▼
Filings for Datascope Corporation span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Datascope Corporation: 67 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Datascope Corporation; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026