Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
Check against the official notice below — it lists the full affected range.
Medtronic is recalling certain Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) devices because they may deliver reduced shock energy—approximately 79% of the programmed energy level—during high-voltage therapy. The recall affects 866 units of Model Numbers DTPC2D4 and DTPC2D that were distributed worldwide. Patients can identify affected devices by checking their specific serial numbers against the list provided in the recall notice.
The source document does not specify a remedy or recommended course of action for affected consumers. Patients with these devices should contact their healthcare provider or Medtronic directly for guidance on next steps.
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: 866 units Lot/code info: a. Model Numbers: DTPC2D4: GTIN 00763000178291, Serial Numbers: RTW600120S, RTW600307S; GTIN 00763000178314, Serial Numbers: RTW600018S, RTW600020S, RTW600022S, RTW600025S, RTW600027S, RTW600028S, RTW600029S, RTW600032S, RTW600033S, RTW600034S, RTW600038S, RTW600040S, RTW600041S, RTW600045S, RTW600232S, RTW600316S, RTW600318S, RTW600321S, RTW600324S, RTW600334S, RTW600335S, RTW600336S, RTW600340S, RTW600341S, RTW600344S, RTW600351S, RTW600356S, RTW600359S, RTW600360S, RTW600361S, RTW600364S, RTW600387S, RTW600388S, RTW600389S, RTW600390S, RTW600391S, RTW600392S, RTW600393S, RTW600394S, RTW600395S, RTW600396S, RTW600397S, RTW600398S, RTW600399S, RTW600400S, RTW600401S, RTW600403S, RTW600404S, RTW600405S, RTW600408S, RTW600410S, RTW600412S, RTW600413S, RTW600415S, RTW600417S, RTW600419S, RTW600420S, RTW600421S, RTW600422S, RTW600425S, RTW600426S, RTW600427S, RTW600428S, RTW600430S, RTW600433S, RTW600436S, RTW600441S, RTW600444S, RTW600445S, RTW600449S, RTW600450S, RTW600452S, RTW600453S, RTW600454S, RTW600456S, RTW600459S, RTW600461S, RTW600463S, RTW600465S, RTW600466S, RTW600467S, RTW600468S, RTW600469S, RTW600470S, RTW600471S, RTW600474S, RTW600476S, RTW600478S, RTW600479S, RTW600481S, RTW600482S, RTW600486S, RTW600487S, RTW600488S, RTW600489S, RTW600490S, RTW600492S, RTW600493S, RTW600494S, RTW600495S, RTW600496S, RTW600497S, RTW600498S, RTW600500S, RTW600501S, RTW600502S, RTW600503S, RTW600505S, RTW600506S, RTW600507S, RTW600508S, RTW600509S, RTW600510S, RTW600511S, RTW6005
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.