FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
- Recall number
- Z-0657-2020
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
- Status
- Open, Classified
- Initiated
- 2019-10-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
- Root cause
- Process control
- Action
- On 10/24/2019, Medtronic sent a "URGENT: MEDICAL DEVICE RECALL" notification to consignees via FedEx. The customer notification letter as consignees to do the following: 1. Identify, segregate, and quarantine affected products within your inventory 2. Complete the Customer Confirmation Form. Return the form to Medtronic via email at RS.NavFCA@Medtronic.com or via fax at 651-367-7075 within 30 days of receipt. 3. Contact Medtronic at 1-888-826-5603 to receive a return materials authorization (RMA) and schedule replacement product. Return affected products to: 4. Medtronic Product Services, Attention: RMA #, 1480 Arthur Ave Louisville, CO 80027 5. If you have questions E-mail Medtronic at RS.NavTechSupport@Medtronic.com or call 1-888-826-5603.
- Quantity
- 10,448 disposable biopsy needles
- Distribution
- US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine,Maryland,Massachusetts,Michigan,Minnesota,Mississippi,Missouri,Montana,Nebraska,Nevada,New Hampshire,New Jersey,New Mexico,New York,North Carolina,North Dakota,Ohio,Oklahoma,Oregon,Pennsylvania,South Carolina,South Dakota,Tennessee,Texas,Utah,Vermont,Virginia,Washington,West Virginia,Wisconsin,Wyoming, OUS: None: Australia, Austria,Bangladesh,Belgium,Bosnia And Herzegovina,Brazil,Bulgaria,Canada,Canary Islands,China,Colombia,Costa Rica,Croatia,Czech Republic,Denmark,Ecuador,Egypt,Finland,France,Germany,Greece,Hungary,Iceland,India,Indonesia,Ireland,Israel,Italy,Japan,Jordan,Kazakhstan,Kenya,Korea, Republic Of,Latvia,Lebanon,Luxembourg,Malaysia,Martinique,Mexico,Netherlands,New Zealand,Pakistan,Philippines,Poland,Portugal,Puerto Rico,Qatar,Reunion,Romania,Russian Federation,Saudi Arabia,Serbia,Slovakia,Slovenia,South Africa,Spain,Sweden,Switzerland,Thailand,Turkey,United Arab Emirates,United Kingdom
- Lot, serial or model codes
- Lot Numbers: 66503918A 066513519A 066529218A 066535518A 66503919 066513519C 66531018 066512319A 066513519E 066531018A 066512319C 66529218 66535518
- 510(k) numbers
- ["K971247"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28