Food, drugs, devices › Medtronic Navigation, Inc.
Device recall: Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943
Medtronic Navigation, Inc. (Louisville, CO) initiated this device recall on 30 Oct 2019; FDA lists 3 product records under event 84191, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Medtronic Navigation, Inc. has 44 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Navigation, Inc., Louisville, CO.
Reason for recall
"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."
Distribution
"US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0657-2020 | Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 | 10,448 disposable biopsy needles | Class II | Ongoing | 18 Dec 2019 |
| Z-0658-2020 | Biopsy Needle FPU Kit, Product # 9731754, UDI: 00643169341517 | 12 disposable biopsy needles | Class II | Ongoing | 18 Dec 2019 |
| Z-0659-2020 | Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 | 1 disposable Biopsy Needle | Class II | Ongoing | 18 Dec 2019 |
Context
Other enforcement events for Medtronic Navigation, Inc.
All 44 events for Medtronic Navigation, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: Alabama, Alaska,Arizona,Arkansas,California,Colorado,Connecticut,Delaware,District of Columbia,Florida,Georga, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.