St Jude Ellipse ICD Recall for Wireless Communication Loss
St Jude Medical is recalling 256 Ellipse ICDs because past updates may cause loss of wireless communication, preventing remote patient monitoring.
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: The recall is classified as FDA Class II. The hazard involves the loss of remote monitoring capability for a life-sustaining medical device, which poses a risk of harm if a cardiac event occurs and is not detected, although no injuries or illnesses have been reported in the source text.
Plain-English summary
St Jude Medical, Cardiac Rhythm Management Division, is recalling 256 units of the Ellipse, Tiered-therapy Cardioverter/Defibrillator. The affected devices are used in conjunction with the Merlin Patient Care System with software model 3330. The recall covers specific serial numbers and reference codes listed in the official FDA notice.
The recall is being issued because past updates to programmers and transmitters may lead some implantable cardioverter defibrillators (ICD) to lose wireless radiofrequency (RF) communication. When this occurs, patients can no longer be interrogated with wireless RF telemetry or monitored remotely. The devices were distributed in 19 U.S. states and 23 countries outside the United States.
Patients and healthcare providers should contact St Jude Medical or their implanting physician to determine if their specific device is affected and to discuss alternative monitoring methods. The source text does not report any illnesses or injuries associated with this defect.
The recalled product
- Product
- Ellipse, Tiered-therapy Cardioverter/Defibrillator, REF (UDI/GTIN): CD1377-36QC (05414734507646), CD2411-36C (05414734507585), CD1277-36 (05414734506045), CD1377-36C (05414734507622), CD2277-36Q (05414734505932), CD2377-36QC (05414734507523), with Merlin Patient Care System with…
- Affected units
- 256
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 (20)
- Serial #: 1138400
- 1138406
- 1138391
- 1138393
- 1138403
- 1138366
- 1138387
- 1138396
- 1138386
- 1138399
- 1138374
- 1138362
- 1138368
- 1138397
- 1138401
- 1138372
- 1138375
- 1138382
- 1138380
- 1138405
Distribution
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