Abbott Merlin pacemaker programmer may fail to terminate threshold test
Merlin Patient Care System programmer software is being recalled because a malfunction during a pacing capture threshold test may stop the command to terminate the test being communicated.
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: FDA Class II recall where a pacing test may not terminate on command, a risk of harm with no injuries reported in the source.
Plain-English summary
The Merlin Patient Care System (PCS) software for the Merlin PCS 3650 programmer, software model 3330, GTIN 05414734509725, is being recalled. Affected software versions are 25.0.1 through 28.7.1 in the United States, varying by region. The action covers 11,182 programs.
The stated reason is that a software malfunction may occur during the pacing capture threshold test of a pacemaker, resulting in the programmer not successfully communicating the command to terminate the test. The FDA classified the action as Class II.
Distribution was nationwide in the United States, including Puerto Rico. The programmers are used by clinicians rather than sold to consumers.
Facilities should identify affected programmers using the model numbers, GTIN and software versions above and follow the instructions issued by Abbott Medical.
The recalled product
- Product
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
- Manufacturer
- Abbott Medical
- Affected units
- 11,182
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 (4)
- Programmer Model 3650
- Software Model 3330
- GTIN 05414734509725
- Software Versions 25.0.1 - 28.7.1 in the United States (varies based on region)
Distribution
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