Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported July 24, 2019
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this re…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Datascope Corp. recalled Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular u… - a critical-severity action.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular u… was recalled by Datascope Corp. in July 24, 2019. Reason: Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and …. Check the official notice for the remedy. Verify recall #Z-1939-2019 with the FDA Devices before acting.
The recall
Datascope Corp. issued this critical-severity FDA Devices recall-Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and ….
- Critical
- severity level
- 6K units
- affected scope
- Class I
- classification
- July 24, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1939-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1939-2019) was formally reported on July 24, 2019, with the manufacturer initiating the action on June 17, 2019. It is classified under Critical severity (Class I), with a current status of Ongoing. Datascope Corp. is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 6,197.
The documented reason for this recall is: Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled… Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTU…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6,197
Related Recalls
6
3 from same agency
Product description
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
Reason for recall
Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1939-2019 |
| Date reported | July 24, 2019 |
| Date initiated | June 17, 2019 |
| Recalling firm | Datascope Corp. |
| Firm location | Mahwah, NJ |
| Affected scope | 6,197 |
| Distribution | Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTUGAL , BAHRAIN , IREL… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1939-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.. Recalled by Datascope Corp.. Units affected: 6,197.
Why was this product recalled? ▼
Battery short-run times and unanticipated stoppage may be due to user not performing battery maintenance and handling as needed. Inadequate labeling is being targeted for this recall, and design updates will be handled in a subsequent recall.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 24, 2019. Severity: Critical. Recall number: Z-1939-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US Nationwide, AFGHANISTAN , HUNGARY , PANAMA , ALGERIA , ICELAND , PARAGUAY , ARGENTINA , INDIA , PERU , AUSTRALIA , INDONESIA , PHILIPPINES , AUSTRIA , IRAN , POLAND , AZERBAIJAN , IRAQ , PORTUGAL , BAHRAIN , IRELAND , QATAR , BANGLADESH , ISRAEL , ROMANIA , BELARUS , ITALY , RUSSIA , BELGIUM , JAPAN , SAUDI ARABIA , BOLIVIA , JORDAN , SERBIA , BOSNIA AND HERZEGOVINA , KAZAKHSTAN , SINGAPORE , BRAZIL , KENYA , SLOVAKIA , BRUNEI , KOSOVO , SLOVENIA , BULGARIA , KUWAIT , SOUTH AFRICA , CAMBODIA , LATVIA , SOUTH KOREA , CANADA , LEBANON , SPAIN , CHILE , LIBYA , SRI LANKA , CHINA , LITHUANIA , SWEDEN , COLOMBIA , LUXEMBOURG , SWITZERLAND , COSTA RICA , MACAU , SYRIA , CROATIA , MACEDONIA , TAIWAN , CYPRUS , MALAYSIA , TANZANIA , CZECH REPUBLIC , MALDIVES , THAILAND , DENMARK , MALTA , TRINIDAD , DOMINICAN REP , MARTINIQUE , TUNISIA , ECUADOR , MAURITIUS , TURKEY , EGYPT , MEXICO , TURKMENISTAN , EL SALVADOR , MOROCCO , UGANDA , ESTONIA , MYANMAR , UKRAINE , FINLAND , NAMIBIA , UNITED ARAB EMIRATES , FRANCE , NEPAL , UNITED KINGDOM , GEORGIA , NETHERLANDS , URUGUAY , GERMANY , NEW ZEALAND , UZBEKISTAN , GHANA , NIGERIA , VENEZUELA , GREECE , NORTH KOREA , VIETNAM , GUATEMALA , NORWAY , YEMEN , GUYANA , OMAN , ZAMBIA , HONDURAS , PAKISTAN , HONG KONG , and PALESTINE..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1939-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 24, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.