CLASS II Device recall · Reported 3 Oct 2012 · FDA Enforcement Report
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO recalled
Greatbatch Medical is recalling Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, distributed in Massachusetts. The recall was initiated on 6 Sep 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2459-2012
- FDA event ID
- 63141
- Recalling firm
- Greatbatch Medical, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2012
- FDA classified
- 26 Sep 2012
- Reported
- 3 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 6 Sep 2012 | Recall initiated by company | |
| 26 Sep 2012 | Classified by FDA | +20 days |
| 3 Oct 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 transvenous introduction of diagnostic / therapeutic catheters into the vasculature and into the chambers of the heart.
Where it was distributed
Distributed in MA.
Questions about this recall
Is Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO recalled?
Yes. Greatbatch Medical recalled Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO on 6 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-2459-2012.
Why was it recalled?
During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to display varying degrees of damage that could pose an embolic risk to a patient.
Which lots are affected?
Q2112752, Q2110939, Q2130137, Q2131250, Q2130212, Q2150143, W2162515, W2163769, W2160626, W2175891, W2172722, W2184492, W2196366, W2184490, W2205843
Where was it sold?
Distributed in MA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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