CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
Medtronic Invos, Reusable Sensor Cable for PM7100 recalled by Covidien
Covidien is recalling Medtronic Invos, Reusable Sensor Cable for PM7100, distributed in 22 states. The recall was initiated on 9 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1732-2024
- FDA event ID
- 93883
- Recalling firm
- Covidien, Boulder, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jan 2024
- FDA classified
- 30 Apr 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2024 | Recall initiated by company | |
| 30 Apr 2024 | Classified by FDA | +112 days |
| 8 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
Where it was distributed
US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal Romania Slovakia Spain Sweden Switzerland Taiwan United Kingdom
AlaskaArizonaCaliforniaConnecticutFloridaGeorgiaIowaLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew YorkPennsylvaniaSouth CarolinaTennesseeTexasVirginia
Questions about this recall
Why was it recalled?
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel
Which lots are affected?
Lot # 2023-02-22, 2023-04-28, 2023-05-04, 2023-07-20; UDI: 10884521780125
Where was it sold?
US: AK AZ CA CT FL GA IA IN LA MA MD MI MN MO NC NY OH OK PA SC TN TX VA WA WI OUS: Australia Austria Belgium Canary Islands Chile Czech Republic Denmark Finland France Germany Guatemala Indonesia Ireland Italy Japan Korea, Republic Of Kuwait Lithuania Mayotte New Zealand Nicaragua Poland Portugal Romania Slovakia Spain Sweden Switzerland Taiwan United Kingdom
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 93883This product is part of a recall event; the main page for the event is Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100 recalled | Covidien | Device Malfunction | 22 states |
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