Recall record at a glance
| Official record | Z-2020-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Ongoing |
| Recalling firm | Boston Scientific Corporation |
| Report date | Jul 21, 2021 |
| Recall initiation date | Jun 3, 2021 |
| Quantity | 3634 units |
| Location | Saint Paul, MN, United States |
Official product description
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Why the product was recalled
The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population
Distribution information
Worldwide distribution.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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