Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
Check against the official notice below — it lists the full affected range.
Medtronic Inc. has recalled approximately 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) that were distributed worldwide. These devices may deliver reduced shock energy, approximately 79% of the programmed energy level, during high-voltage therapy. The affected devices include specific model numbers and serial numbers identified by Medtronic.
The record does not specify a remedy or recommended action for consumers who have received these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
Reason for recall: There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Distribution: Worldwide Distribution Quantity: 8429 units Lot/code info: a. Model Numbers: DTPA2D4: GTIN 00763000178130, Serial Numbers: RTG600136S, RTG600270S, RTG601323S, RTG601338S, RTG601367S, RTG601433S, RTG601484S, RTG601489S, RTG601575S, RTG601583S, RTG601595S, RTG601632S, RTG601643S, RTG601653S, RTG601657S, RTG601669S, RTG601775S, RTG601790S, RTG601802S, RTG601805S, RTG601820S, RTG601847S, RTG601892S, RTG601904S, RTG601968S, RTG602017S, RTG602019S, RTG602125S, RTG602147S, RTG602179S, RTG602182S, RTG602191S, RTG602207S, RTG602209S, RTG602221S, RTG602226S, RTG602238S, RTG602239S, RTG602360S, RTG602439S, RTG602477S, RTG602480S, RTG602490S, RTG602506S, RTG602512S, RTG602515S, RTG602516S, RTG602524S, RTG602550S, RTG602580S, RTG602584S; GTIN 00763000178154, Serial Numbers: RTG600028S, RTG600029S, RTG600030S, RTG600033S, RTG600036S, RTG600037S, RTG600040S, RTG600048S, RTG600049S, RTG600054S, RTG600055S, RTG600056S, RTG600059S, RTG600060S, RTG600061S, RTG600062S, RTG600063S, RTG600064S, RTG600065S, RTG600066S, RTG600067S, RTG600068S, RTG600069S, RTG600070S, RTG600071S, RTG600072S, RTG600073S, RTG600074S, RTG600075S, RTG600076S, RTG600077S, RTG600079S, RTG600081S, RTG600082S, RTG600083S, RTG600085S, RTG600086S, RTG600087S, RTG600089S, RTG600090S, RTG600091S, RTG600092S, RTG600095S, RTG600096S, RTG600097S, RTG600098S, RTG600099S, RTG600100S, RTG600101S, RTG600104S, RTG600105S, RTG600106S, RTG600107S, RTG600108S, RTG600110S, RTG600111S, RTG600112S, RTG600113S, RTG600114S, RTG600115S, RTG600116S, RTG600117S, RTG600118S, RTG600119S, RTG600120S, RTG6001
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.