Medtronic Implantable Defibrillator Recalled for Manufacturing Weld Defect
Medtronic recalls 26 units of CROME HF QUAD CRT-D implantable defibrillators worldwide due to weld cracks discovered during manufacturing quality control. Devices were contained before reaching patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for manufacturing defect (weld cracks) in implantable cardioverter defibrillator. No illnesses or injuries reported; defect was identified during manufacturing quality control before patient distribution. Risk of potential device failure in a critical cardiac implant justifies High severity.
Plain-English summary
Medtronic Inc. is recalling 26 units of CROME HF QUAD CRT-D MRI SureScan implantable cardioverter defibrillators (Model DTPC2QQ). These devices are implanted to regulate heart rhythm in patients with certain cardiac conditions.
The recall is prompted by a manufacturing defect: weld cracks in the device enclosure. During manufacturing, these cracks caused the devices to fail the leak check test, a critical safety verification. All affected units were detected and contained before reaching patients.
The devices were distributed worldwide to multiple U.S. states and over 30 countries. Specific serial numbers and lot information are available through the FDA.
Patients or healthcare providers with concerns should contact Medtronic or consult the official FDA recall notice for device-specific details and recommended actions.
The recalled product
- Product
- CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator
- Manufacturer
- Medtronic Inc.
- Affected units
- 26
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 (20)
- GTIN: 00763000178253
- Serial Number: RTS605244S
- GTIN: 00763000178277
- Serial Numbers: RTS604876S
- RTS604877S
- RTS604879S
- RTS604885S
- GTIN: 00763000711245
- Serial Numbers: RTS604695S
- RTS604698S
- RTS604700S
- RTS604703S
- RTS604704S
- RTS604714S
- RTS604716S
- RTS604717S
- RTS604718S
- RTS604721S
- RTS604722S
- RTS604723S
Distribution
Part of a larger recall action
This product is one of 23 recalled by Medtronic Inc. 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.
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