Medtronic Invos Sensor Cable Recalled for Manufacturing Defects
Covidien is recalling 2,305 units of the Medtronic Invos Reusable Sensor Cable (PMAC71RSC) due to manufacturing defects in sensor cable connectors that may cause error codes or device malfunction.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall affects a patient monitoring sensor. Manufacturing defects may cause sensor malfunction or error codes. No illnesses, injuries, or deaths have been reported. Per the rubric, recalls with no documented harm are at most High severity, even for risk-of-harm products.
Plain-English summary
Covidien is recalling 2,305 units of the Medtronic Invos Reusable Sensor Cable for PM7100 (model PMAC71RSC). Manufacturing defects in the sensor cable connectors may result in error codes or non-functioning sensor channels.
The recalled devices were distributed across the United States and to 31 countries internationally. U.S. distribution included 25 states: Alaska, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and Wisconsin. Affected production lots are: 2023-02-22, 2023-04-28, 2023-05-04, and 2023-07-20 (UDI: 10884521780125).
Healthcare organizations in possession of affected devices should verify their device information and contact Covidien or the FDA with questions or to report any incidents.
The recalled product
- Product
- Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC
- Manufacturer
- Covidien
- Affected units
- 2,305
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # 2023-02-22
- 2023-04-28
- 2023-05-04
- 2023-07-20
- UDI: 10884521780125
Distribution
Part of a larger recall action
This product is one of 2 recalled by Covidien under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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