Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1);

Is my product affected?

Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventricular fibrillation, ventricular

• UPC 00643169705807
• UPC 00643169565272

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Inc. is recalling 951 Compia MRI Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices distributed nationwide in the United States. These devices may fail to deliver high and low voltage therapy, which are critical functions for treating abnormal heart rhythms in patients who have had these implantable devices placed.

The specific affected devices include the Compia MRI CRT-D DF1 (Product No. DTMC1D1 with UDI 00643169705807 and serial number RPW200289H) and Product No. DTMC1QQ (UDI 00643169565272) with multiple associated serial numbers. The recall document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

Details from the source

Reason for recall: Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D). Distribution: US Nationwide Distribution. Quantity: 951 devices total Lot/code info: a. Product No. DTMC1D1: UDI 00643169705807 (Serial No. RPW200289H); b. Product No. DTMC1QQ: UDI 00643169565272 (Serial No. RPL201034H) (EXPANSION: Serial No. RPL200052H, RPL200534H, RPL201039H, RPL201059H, RPL201235H, RPL201236H, RPL201454H, RPL201645H, RPL201664H, RPL201234H)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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• Implantable Cardioverter Defibrillators (ICDs), Evera MRI. Labeled as the following: a. Evera MRI XT DR ICD DF1 (Product No. DDMB1D1); b. Evera MRI XT DR ICD DF4 (Product No. DDMB1D4); c. Evera MRI XT VR ICD DF4 (Product No. DVMB1D4); d. Evera MRI S DR ICD DF1 (Product No. DDMC3D1); EXPANSION: e. Ev2017-12-19
• Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Claria MRI. Labeled as the following: a. Claria MRI CRT-D DF1 (Product No. DTMA1D1); b. Claria MRI Quad CRT-D DF4 (Product No. DTMA1QQ); EXPANSION: c. Claria MRI CRT-D DF4 (Product No. DTMA1D4); d. Claria MRI Quad CRT-D DF1 (Product No. DTMA2017-12-19
• Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. Evera XT VR ICD DF1 (Product No. DV2017-12-19

All FDA (Device enforcement) recalls