Severity
Moderate
FDA Devices recall · Reported August 22, 2012
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
Maquet Inc. recalled Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe… - a moderate-severity action.
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe… was recalled by Maquet Inc. in August 22, 2012. Reason: Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened"…. Check the official notice for the remedy. Verify recall #Z-2210-2012 with the FDA Devices before acting.
The recall
Maquet Inc. issued this moderate-severity FDA Devices recall-Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened"….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2210-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2210-2012) was formally reported on August 22, 2012, with the manufacturer initiating the action on May 29, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Maquet Inc. is listed as the recalling firm, operating out of Wayne, NJ. Federal records list the affected scope as 20 devices US; 122 devices foreign.
The documented reason for this recall is: Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including MI, MN and Internationally. 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.
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.
Severity
Moderate
Affected scope
20 devices US; 122 devices foreign
Related Recalls
6
3 from same agency
Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 info.cp@maquet.com www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures
Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2210-2012 |
| Date reported | August 22, 2012 |
| Date initiated | May 29, 2012 |
| Recalling firm | Maquet Inc. |
| Firm location | Wayne, NJ |
| Affected scope | 20 devices US; 122 devices foreign |
| Distribution | Worldwide Distribution - USA including MI, MN and Internationally |
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.
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.
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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 August 22, 2012. 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.