The Recall Desk
SevereFDA (Devices)·Z-2825-2018·Announced 2018-08-22

Sorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing

Sorin CRM SAS is recalling 10 Platinium CRT-D devices because a hardware issue may cause loss of pacing and sensing, preventing the device from detecting arrhythmias.

What this means for you

Illness, injury, or structural failure has been reported. 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 involves a medical device failure that prevents the delivery of life-saving defibrillation therapy, posing a significant risk of serious injury or death.

Plain-English summary

Sorin CRM SAS is recalling 10 units of the Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator. The recall involves specific serial numbers and is classified as a Class II recall by the U.S. Food and Drug Administration.

The recall is issued because a hardware configuration issue may lead to overconsumption of the device's power, followed by a loss of pacing and sensing capabilities. If this occurs, the device will be unable to identify an arrhythmia that would require defibrillation shock therapy.

The affected devices were distributed in the United States to New Jersey, Arizona, Mississippi, Oklahoma, Louisiana, Pennsylvania, Florida, Michigan, Illinois, and Mississippi. Patients with these specific devices should contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Manufacturer
Sorin CRM SAS
Category
Medical Device — Cardiac Defibrillator
Hazard
Affected units
10

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 (11)

  • Model TDF037U
  • UDI GTIN 08031527015484 Serial Numbers: 637DC0D0
  • 637DC13F
  • 625DC128
  • 622DC17A
  • 620DC034
  • 627DC0E0
  • 619DC101
  • 620DC07F
  • 622DC02C
  • 619DC0E1

Distribution

Distributed in 9 states:

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 →

Same hazard · device failure

See all →