PlainRecalls

Datascope Corporation

Compiled from official public sources by the editorial team.

67 recalls on record · Latest: Nov 2, 2022

Datascope Corporation Recall Insight

Datascope Corporation appears on 67 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.066% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Nov 2, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 47 moderate, and 3 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from May 16, 2018 to Nov 2, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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, 0…

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 …

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: Acu…

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, 0684-0…

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-…

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…

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: A…

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- Prod…

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: A…

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 Co…

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, 06…

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: A…

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, 0684-00-05…

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: Acu…

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 - …

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, …

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…

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 B…

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 Aor…

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…

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. 4…

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 Cu…

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 Byp…

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…

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

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Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.