Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 13, 2021
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medtronic Perfusion Systems recalled Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Steril… - a moderate-severity action.
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Steril… was recalled by Medtronic Perfusion Systems in October 13, 2021. Reason: There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in th…. Check the official notice for the remedy. Verify recall #Z-0003-2022 with the FDA Devices before acting.
The recall
Medtronic Perfusion Systems issued this moderate-severity FDA Devices recall-There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in th….
- Moderate
- severity level
- Class II
- classification
- October 13, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0003-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0003-2022) was formally reported on October 13, 2021, with the manufacturer initiating the action on September 13, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Perfusion Systems is listed as the recalling firm, operating out of Brooklyn Park, MN. Federal records list the affected scope as 168 kits.
The documented reason for this recall is: There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.. 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
168 kits
Related Recalls
6
3 from same agency
Product description
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Reason for recall
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0003-2022 |
| Date reported | October 13, 2021 |
| Date initiated | September 13, 2021 |
| Recalling firm | Medtronic Perfusion Systems |
| Firm location | Brooklyn Park, MN |
| Affected scope | 168 kits |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey. |
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-0003-2022) 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? ▼
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.. Recalled by Medtronic Perfusion Systems. Units affected: 168 kits.
Why was this product recalled? ▼
There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 13, 2021. Severity: Moderate. Recall number: Z-0003-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0003-2022) 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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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 October 13, 2021. 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.