Z-1020-05

Adapter for ACMI Hysteroscope Catalog Number: 55035

Name: Z-1020-05 Adapter for ACMI Hysteroscope Catalog Number: 55035
Creator: Boston Scientific Marlbourgh
Published: 2005-07-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-07-28 / Terminated

FDA source

Boston Scientific Marlbourgh began a recall of Adapter for ACMI Hysteroscope Catalog Number: 55035 on 2005-07-28. The reason FDA records is "The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1020-05
Status: Terminated
Initiated: 2005-07-28
Posted: 2005-07-19
Terminated: 2006-06-14
Recalling firm: Boston Scientific Corporation
Product: Adapter for ACMI Hysteroscope Catalog Number: 55035
Product code: MNB Device, Thermal Ablation, Endometrial
Reason for recall: The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.
FDA root cause: Other
Action: Boston Scientifc notified accounts by letter dated June 28, 2005 via Federal Express. Accounts are requested to check invnetory and return. Any adapters out of box have no lot identification and can be tested per instructions
Distribution: CA, DE, FL, MA, MO, MS, OH, NE, NY, PA, UT, WI
Product codes and lots: Lot Number: 20410191

Product code MNB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)