Medtronic Recalling 21 Different CRT-Ds and ICDs

MedtronicThe FDA announced a Class 1 recall by Medtronic of a laundry list of its cardiac resynchronization with defibrillation (CRT-D) and implantable cardioverter-defibrillator (ICD) devices.

A manufacturing defect can allow a faulty mix of gases inside these devices, the FDA said, keeping them from delivering shocks for pacing or reviving patients in cardiac arrest.

Medtronic devices under recall include those in the Amplia, Claria, Compia, and Viva lines of CRT-Ds and a number of types of Evera and Visia ICDs. Affected devices were manufactured from July 13, 2013, through August 8, 2017.

Patients with a recalled device should be considered for prophylactic replacement, for which Medtronic said it is offering a supplemental warranty.

LINK TO FDA RECALL:  https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm598198.htm

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

  • Recalled Product(s): Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs)
  • Product Codes: NIK, LWS
  • Serial Numbers: See Complete List
  • Manufacturing Dates: July 13, 2013 to August 8, 2017
  • Devices Recalled in the U.S.: 48 units nationwide

Device Use:

Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.

ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.

Reason for Recall

Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process.  This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest.

The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.

Who is affected?

  • Patients with an affected Medtronic ICD or CRT-D device
  • Caregivers of patients with an affected Medtronic ICD or CRT-D device
  • Health care providers treating patients with heart failure or heart rhythm problems using affected Medtronic ICD or CRT-D devices

What to Do:

On January 22 2018 Medtronic sent an Urgent Medical Device Recall notice to affected customers. The notice asked customers to:

  • Consider Prophylactic device replacement for patients who have been implanted with one of the affected devices.
  • Contact their Medtronic sales representative for terms and conditions for device warranties.
  • Review the recall notice and ensure appropriate staff is aware of the notice.

Medtronic will offer a supplemental device warranty for affected devices.

Contact Information

Customers who have questions or need additional information or support regarding this recall should contact their local Medtronic sales representative or Medtronic Technical Services at 800-723-4636.

Patients can contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time).

Date Recall Initiated

January 22, 2018

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.

Complete List of Serial Numbers

Cardiac Resynchronization Therapy
with Defibrillation (CRT-Ds)
Device Model Device Serial
Number
Amplia MRI CRT-D DF4 DTMB1D4 RPJ201956H
Amplia MRI Quad CRT-D DF4 DTMB1QQ RPE201417H
RPE204789H
RPE206207H
RPE207850H
RPE209095H
RPE212027H
Claria MRI Quad CRT-D DF4 DTMA1QQ RPA204495H
Compia  MRI Quad CRT-D DF4 DTMC1QQ RPL201034H
Viva Quad S CRT-D DF4 DTBB1QQ BLK204122H
Viva Quad XT CRT-D DF4 DTBA1QQ BLC224272H
BLC227175H
BLC227641H
Viva S CRT-D DF1 DTBB1D1 BLO204984H
Viva XT CRT- D DF1 DTBA1D1 BLF216780H
BLF231229H
BLF250740H
BLF251155H
BLF255165H
Viva XT CRT- D DF4 DTBA1D4 BLE220200H

Implantable Cardiovert-
Defibrillators (ICDs)
Device Model Device Serial
Number
Evera MRI XT DR ICD DF1 DDMB1D1 CWA200012H
CWA202259H
CWA203498H
Evera MRI XT DR ICD DF4 DDMB1D4 PFZ214605H
PFZ228504H
PFZ228590H
PFZ228836H
PFZ228838H
PFZ229236H
Evera MRI XT VR ICD DF4 DVMB1D4 PKZ203327H
PKZ210673H
Evera MRI S DR ICD DF1 DDMC3D1 CWC200055H
Evera S DR ICD DF1 DDBC3D1 BWG204574H
Evera S VR ICD DF1 DVBC3D1 BWM204635H
Evera XT DR ICD DF1 DDBB1D1 BWC223253H
BWC233374H
BWC234767H
BWC234772H
Evera XT VR ICD DF1 DVBB1D1 BWI208876H
Evera XT VR ICD DF4 DVBB1D4 BWH201158H
BWH214640H
Visia AF MRI VR SureScan ICD DF1 DVFB1D1 CWG200402H
Visia AF MRI VR SureScan ICD DF4 DVFB1D4 PKX202448H
PKX205417H
PKX205779H
PKX209277H
PKX212710H
Visia AF VR ICD DF1 DVAB1D1 BWN201126H
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