Medtronic Navigation, Inc. recalls Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile…
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Read the official notice →- Date
- 2025-02-05
- Country
- United States
- Brand
- Medtronic Navigation
- Product
- Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Medtronic Navigation recalls
- 2024-10-16
USMedtronic Navigation, Inc. recalls StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is…
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing…
FDA · DeviceMedtronic Navigation, Inc.Worldwide - U.S Nationwide distribution including in the states of AK, AR, AZ,…Official notice →- 2024-05-15
- US
Medtronic Navigation, Inc. recalls Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating…
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
FDA · DeviceMedtronic Navigation, Inc.Worldwide distribution. US nationwide including Puerto Rico, Argentina,…Official notice → - 2024-01-17
- US
Medtronic Navigation, Inc. recalls Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
Their is the potential that the percutaneous pin may have a cross-pin that may render the pin unable to fit into tap cap, or too tight to remove.
FDA · DeviceMedtronic Navigation, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA and the…Official notice → - 2023-11-15
- US
Medtronic Navigation, Inc. recalls StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is…
Due to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location.
FDA · DeviceMedtronic Navigation, Inc.Worldwide Distribution: U.S. (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice → - 2023-06-14
- US
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems
In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain…
FDA · DeviceMedtronic Navigation, Inc.US Distribution: PR. OUS (foreign) distribution: ARGENTINA, AUSTRALIA,…Official notice → - US
Medtronic Navigation, Inc. recalls StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information…
FDA · DeviceMedtronic Navigation, Inc.Worldwide Distibution: US (nationwide): OH, IL, CA, MI, FL, LA, OK, WA, AR,…Official notice →
Other drugs & medical recalls in the United States
- 2025-02-05
- US
Zimmer, Inc. recalls NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm, Item Number 00-5994-032-10
It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
FDA · DeviceZimmer, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, GA, KS, MO,…Official notice → - US
Boston Scientific Corporation recalls AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
FDA · DeviceBoston Scientific CorporationNationwide including Puerto Rico Foreign: To be providedOfficial notice → - US
Accuray Incorporated recalls CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery…
Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
- US
B. Braun Medical, Inc. recalls Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural…
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore…
FDA · DeviceB. Braun Medical, Inc.US Nationwide distribution in the states of MO, OK.Official notice → - US
Instrumentation Laboratory recalls HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
FDA · DeviceInstrumentation LaboratoryWorldwide - US Nationwide and the countries of Andorra, Algeria, Armenia,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY, Item Number ART600; 2) A LINE TRAY, Item Number ART690
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.