FDA Device recall Z-2766-2015
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU2006…
- FDA Device
- Class II
- terminated
- Published 2015-09-23
On 2015-09-23 the FDA classified a Class II recall of Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU2006… by Boston Scientific, citing cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2766-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-25 |
| Published | 2015-09-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F Single curve( M635TU10060, TU1006) , 14F Double curve (M635TU20060, TU2006) , & 14F Anterior curve (M635TU40060, TU4006). For cardiac use.
Reason
Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, possibly preventing subsequent sealing of the valve when desired. This Field Correction reinforces the Directions for Use (DFU) and gives further guidance on correct use of the hemostasis valve to avoid cross-threading and to securely seal the valve, minimizing potential for undesired blood leakage.
Identifiers
| code_info | 15611295 15624432 15653185 15657827 15675111 15640386 15679748 15684667 15698742 15716330 15736494 15736689…15611295 15624432 15653185 15657827 15675111 15640386 15679748 15684667 15698742 15716330 15736494 15736689 15746782 15711284 15753133 15757057 15760114 15764019 15767450 15768507 15770114 15772280 16635566 16691146 17148680 17628922 16675497 16723382 16731675 16738582 16740109 16752661 16760782 16880335 16897923 16904754 16751834 16893570 16894795 16933430 16937185 16940509 16943256 17038874 17041892 17044130 17046074 17123055 17126755 17127496 17133735 17138028 17206369 17210088 17211902 17214752 17218900 17296059 17300015 17388374 17388375 17388376 17388377 17453643 17453644 17708567 17708568 17708569 17708570 18014966 18014967 18014968 18075932 18075933 18075934 18075935 18110488 18204409 18204410 18204411 F00548801 F00548802 F00548803 F00548804 F00548805 F00548806 F00548807 F00548808 F00548809 F00548810 F00548811 F00548812 F00548813 F00548814 F00548815 F00548816 F00548817 F00548818 F0 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2766-2015%22
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