Boston Scientific Z Flex 270 Steerable Sheath Recalled for Embolic Risk
Greatbatch Medical is recalling 787 units of Boston Scientific Z Flex 270 Steerable Sheaths because damaged internal liners could pose an embolic risk to patients.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (damaged liners) that poses a significant risk of harm (embolic risk) to patients, meeting the criteria for a Severe rating.
Plain-English summary
Greatbatch Medical is recalling 787 units of the Boston Scientific Z Flex 270 Steerable Sheath, a sterile, prescription-only medical device used to facilitate the transvenous introduction of diagnostic and therapeutic catheters into the vasculature and heart chambers. The device is distributed by Boston Scientific Corporation and manufactured by Greatbatch Medical.
The recall was initiated after an investigation of four returned sheaths used with cardiac cryoablation balloon catheters revealed that the internal PTFE sheath liners displayed varying degrees of damage. This damage could pose an embolic risk to patients. The affected units were distributed in Massachusetts.
Healthcare providers and facilities should stop using the recalled devices and contact Greatbatch Medical for further instructions. Consumers should not use these prescription-only devices and should consult their healthcare provider if they have questions regarding the recall.
The recalled product
- Product
- Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate transv
- Manufacturer
- Greatbatch Medical
- Affected units
- 787
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 (15)
- Q2112752
- Q2110939
- Q2130137
- Q2131250
- Q2130212
- Q2150143
- W2162515
- W2163769
- W2160626
- W2175891
- W2172722
- W2184492
- W2196366
- W2184490
- W2205843
Distribution
Distributed in 1 state:
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