Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 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.
Potential Endotoxin Contamination
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Datascope Corporation recalled Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 06… - a moderate-severity action.
Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 06… was recalled by Datascope Corporation in September 2, 2020. Reason: Potential Endotoxin Contamination. Check the official notice for the remedy. Verify recall #Z-2841-2020 with the FDA Devices before acting.
The recall
Datascope Corporation issued this moderate-severity FDA Devices recall-Potential Endotoxin Contamination.
- Moderate
- severity level
- Class II
- classification
- September 2, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2841-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2841-2020) was formally reported on September 2, 2020, with the manufacturer initiating the action on July 27, 2020. It is classified under Moderate severity (Class II), with a current status of Ongoing. Datascope Corporation is listed as the recalling firm, operating out of Fairfield, NJ. Federal records list the affected scope as 2550 Kits.
The documented reason for this recall is: Potential Endotoxin Contamination Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Jap…. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2550 Kits
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Potential Endotoxin Contamination
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2841-2020 |
| Date reported | September 2, 2020 |
| Date initiated | July 27, 2020 |
| Recalling firm | Datascope Corporation |
| Firm location | Fairfield, NJ |
| Affected scope | 2550 Kits |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Neth… |
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-2841-2020) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
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.. Recalled by Datascope Corporation. Units affected: 2550 Kits.
Why was this product recalled? ▼
Potential Endotoxin Contamination
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2020. Severity: Moderate. Recall number: Z-2841-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2841-2020) 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.
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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 September 2, 2020. 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.