Mammotome Revolve Dual Vacuum Assist Biopsy recallZ-1512-2017 · Devicor Medical Products Inc · initiated Feb 28, 2017
Class II Terminated All recalls posted in March 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Devicor Medical Products Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
FDA root cause category: Process control
What the company is doing
Devicor sent an Urgent Medical Device Recall letter dated March 10, 2017 to all affected consignees via first class mail. The recall response rate will be tracked and reconciled by consignee's response form, certifications of product inventory, and/or disposal. Consignees were asked to complete and return the enclosed response form as soon as possible. Consignees with any questions were instructed to call Mammotome Customer Service at 1-877-926-2666. For questions regarding this recall call 513-864-9158.
Recall details
- Recall number
- Z-1512-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 28, 2017
- Posted by the FDA
- Mar 8, 2017
- Recalling firm
- Devicor Medical Products Inc
- Quantity
- 320
- Product code
- KNW
- FDA submissions
- K152989
- Distribution
- Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
Product description
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Code information (models, lots, serial numbers)
F11621304D1
Other devices under the same FDA submission
12 devices cleared under K152989 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Mammotome revolve MST1009Devicor Medical Products, Inc. · Instrument, Biopsy8 reports
- Mammotome revolve MHUS08Devicor Medical Products, Inc. · Instrument, Biopsy7 reports
- Mammotome revolve CA000399017Devicor Medical Products, Inc. · Instrument, Biopsy6 reports
- Mammotome revolve MST0809Devicor Medical Products, Inc. · Instrument, Biopsy5 reports
- Mammotome revolve MSTH1Devicor Medical Products, Inc. · Instrument, Biopsy2 reports
- Mammotome revolve MST0812Devicor Medical Products, Inc. · Instrument, Biopsy2 reports
- Mammotome revolve CA000399016Devicor Medical Products, Inc. · Instrument, Biopsy2 reports
- Mammotome revolve CA000400003Devicor Medical Products, Inc. · Instrument, Biopsy2 reports
- Mammotome revolve MST1012Devicor Medical Products, Inc. · Instrument, Biopsy1 report
- Mammotome revolve MHUS10Devicor Medical Products, Inc. · Instrument, Biopsy1 report
- Mammotome revolve DIRECT MARK GTINDevicor Medical Products, Inc. · Instrument, Biopsy1 report
- Mammotome revolve CA000399007Devicor Medical Products, Inc. · Instrument, Biopsy1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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