Sorin Platinium CRT-D Recall Due to Pacing and Sensing Loss
Sorin CRM SAS is recalling 16 Platinium CRT-D devices because a hardware defect may cause loss of pacing and sensing, preventing the device from delivering necessary defibrillation.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves the failure of a life-sustaining medical device (defibrillator) to deliver therapy, which constitutes a significant risk of serious injury or death.
Plain-English summary
Sorin CRM SAS is recalling 16 units of the Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator. The recall is due to a hardware configuration issue that may lead to overconsumption of the device's power, resulting in the loss of pacing and sensing capabilities.
If the device loses these capabilities, it cannot identify an arrhythmia that would require defibrillation shock therapy. This means the device may fail to deliver life-saving treatment if a patient experiences a dangerous heart rhythm.
The affected devices were distributed in the United States to New Jersey, Arizona, Mississippi, Oklahoma, Louisiana, Pennsylvania, Florida, Michigan, Illinois, and Mississippi. The specific serial numbers for the 16 recalled units are: 619DK0FB, 618DK003, 619DK0C0, 622DK03B, 622DK12A, 624DK070, 624DK12F, 619DK021, 627DK0B0, 618DK0A4, 619DK097, 620DK065, 619DK09B, 619DK05F, 619DK088, and 619DK0CC. Patients with these devices should contact their healthcare provider for evaluation and potential replacement.
The recalled product
- Product
- Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
- Manufacturer
- Sorin CRM SAS
- Affected units
- 16
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 (17)
- Model TDF033U
- UDI GTIN 08031527015538 Serial Numbers: 619DK0FB
- 618DK003
- 619DK0C0
- 622DK03B
- 622DK12A
- 624DK070
- 624DK12F
- 619DK021
- 627DK0B0
- 618DK0A4
- 619DK097
- 620DK065
- 619DK09B
- 619DK05F
- 619DK088
- 619DK0CC
Distribution
Part of a larger recall action
This product is one of 2 recalled by Sorin CRM SAS 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Sorin CRM SAS
See all →- SevereSorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing
FDA (Devices) · 2018-08-22
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