SeekerRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 81
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 2
We found 9 models of Seeker by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between May 18, 2017 and Sep 2, 2026 — classified as 7 injuries, 74 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (43 reports).
2 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Seeker recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 16, 2018Terminated
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
Z-1803-2018 · Root cause: Process control · Recall details · FDA record ↗
- Apr 16, 2018Terminated
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
Z-1802-2018 · Root cause: Process control · Recall details · FDA record ↗
Most reported Seeker problems
Device problems
- Detachment of Device or Device Component43
- Break29
- Material Deformation12
- Packaging Problem9
- Retraction Problem7
- Device-Device Incompatibility6
- Device Markings/Labelling Problem3
- Device Contamination with Chemical or Other Material2
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Patient Involvement4
- Foreign Body In Patient3
- Device Embedded In Tissue or Plaque1
Seeker models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Seeker® SK15035MCATHETER, PERCUTANEOUS1 recall9 reports
- Seeker® SK15014CATHETER, PERCUTANEOUS1 recall3 reports
- Seeker® SK15018CATHETER, PERCUTANEOUS30 reports
- Seeker® SK9035MCATHETER, PERCUTANEOUS11 reports
- Seeker® SK13518CATHETER, PERCUTANEOUS7 reports
- Seeker® SK13514CATHETER, PERCUTANEOUS6 reports
- Seeker® SK13535MCATHETER, PERCUTANEOUS6 reports
- Seeker® SK9018CATHETER, PERCUTANEOUS5 reports
- Seeker® SK6535MCATHETER, PERCUTANEOUS4 reports
Recent Seeker adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Peeled/Delaminated; Device-Device Incompatibility
On (b)(6) 2026, a patient underwent a recanalization procedure using a Seeker Crossing Support Catheter for the treatment of a calcified superficial femoral artery (SFA) lesion via a contralateral approach. During the procedure, it was reported that the guidewire could not be advanced through the distal tip of the catheter. After multiple attempts, the guidewire was successfully advanced; however, difficulty was subsequently encountered during withdrawal of the guidewire through the distal tip. Upon removal, flaking of the guidewire's polymer coating was observed. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50559365 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
On (b)(6) 2026, a patient underwent a recanalization procedure using a Seeker Support Catheter via femoral access. During the procedure, it was reported that the catheter ruptured while being advanced over a 0.018-inch guidewire. The catheter separated into two pieces. The procedure was subsequently completed using a competitor's catheter. No patient harm was reported, and there was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50559113 ↗MalfunctionAug 28, 2026Detachment of Device or Device Component; Device-Device Incompatibility; Material Deformation
On (b)(6) 2026, prior to a recanalization procedure using a Seeker catheter, the patient presented with ASO in the left lower limb. A V18 guidewire was selected for recanalization, and a Seeker stylet was used in conjunction with it. Upon deployment of the Seeker catheter, a crease was observed on the distal portion of the catheter, preventing the V18 guidewire from passing through the distal tip. As a result, recanalization of the lesion could not be performed with the device. The guidewire was unable to pass through the distal tip. The procedure was completed using another device. There was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50492798 ↗MalfunctionJul 27, 2026Detachment of Device or Device Component
On (b)(6)2026, a patient underwent a recanalization procedure using the Seeker catheter. During the procedure, the catheter was allegedly found fractured. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50032306 ↗InjuryJun 3, 2026Detachment of Device or Device Component; Material Deformation
On (b)(6) 2026, a patient underwent a recanalization procedure using a Seeker catheter. During the procedure, the tip of the catheter split and separated into two pieces, with a portion becoming lodged in the patient. Furthermore, open surgery was performed to remove the part of the catheter that broke off in the patient. The current status of the patient is unknown.
Patient problems: Foreign Body In Patient
MAUDE report 25369967 ↗MalfunctionFeb 17, 2026Retraction Problem; Detachment of Device or Device Component; Device Dislodged or Dislocated; Material Deformation
ON (B)(6) 2026, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING SEEKER. DURING THE PROCEDURE, THE SEEKER CATHETER WAS ALLEGEDLY UNABLE TO REMOVE AND NEEDED TO REMOVE FORCEFUL AND OBSERVED STRUCTURAL DAMAGE TO THE CATHETER WITH THE RADIOPAQUE RING. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24362861 ↗InjuryJan 13, 2026Detachment of Device or Device Component
ON (B)(6) 2025, A PATIENT UNDERWENT A ANGIOPLASTY PROCEDURE USING THE SEEKER CATHETER. DURING THE PROCEDURE, THE SEEKER ALLEGEDLY BROKEN COMPLETELY. IT WAS FURTHER REPORTED THAT THE DETACHED PIECE WAS LEFT INSIDE THE PATIENT. THE CURRENT STATUS OF PATIENT IS UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 24050667 ↗MalfunctionSep 26, 2025Device Contamination with Chemical or Other Material; Device Handling Problem; Device Contamination with Chemical or Other Material; Device Handling Problem
ON (B)(6) 2025, A PATIENT UNDERWENT AN ANGIOPLASTY (PTA) PROCEDURE USING THE SEEKER CATHETER. DURING THE PROCEDURE, THE DOCTOR ACCIDENTALLY DROPPED THE CATHETER AND MADE IT UNCLEAN. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23152188 ↗MalfunctionSep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2025, THE PATIENT UNDERWENT A RECANALIZATION PROCEDURE IN RIGHT COMMON FEMORAL ARTERY USING THE SEEKER. DURING THE PROCEDURE IT WAS REPORTED THAT THE GUIDEWIRE WAS ALLEGEDLY UNABLE TO PASS THROUGH THE OCCLUDED LESION. IT WAS FURTHER REPORTED THAT THE HEAD END OF THE SUPPORT CATHETER BROKE, DURING THE OPENING PROCESS. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931079 ↗MalfunctionAug 28, 2025Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation
ON (B)(6) 2025, A PATIENT PREPPED FOR A RECANALIZATION PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE SEEKER CATHETER ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22910751 ↗MalfunctionJul 2, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE SEEKER CATHETER. PRIOR TO THE PROCEDURE, THE SUPPORT CATHETER SEEKER WAS ALLEGEDLY FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22380747 ↗MalfunctionJun 11, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
ON (B)(6) 2025, A 86-YEAR-OLD MALE PATIENT UNDERWENT A SEEKER PROCEDURE. DURING THE PROCEDURE, THE CATHETER HUB FULLY SEPARATED OUTSIDE THE BODY AND STILL ON WIRE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22182065 ↗MalfunctionJun 2, 2025Break; Flushing Problem; Device-Device Incompatibility; Material Twisted/Bent; Break; Flushing Problem; Device-Device Incompatibility; Material Twisted/Bent
ON (B)(6) 2025, A PATIENT UNDERWENT A RECANALIZATION PROCEDURE USING THE SEEKER SUPPORT CATHETER. PRIOR TO THE PROCEDURE, IT WAS FELT MORE RESISTANCE WHEN PERFORMING THE FLASH OUTSIDE THE BODY. IT WAS FURTHER REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE GOT CAUGHT ON THE CATHETER TIP. REPORTEDLY, THE CATHETER WAS SLIGHTLY BENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22122040 ↗InjuryApr 7, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE, THE HEAD END OF THE SUPPORT CATHETER WAS ALLEGEDLY FOUND TO HAVE A SPLIT. IT WAS FURTHER REPORTED THAT IT WAS CONFIRMED AFTER THE EXIT OF THE SUPPORT CATHETER THAT THE HEAD END HAD BEEN SPLIT. REPORTEDLY, THE SEPARATED PART WAS REMOVED BY CUTTING THE BLOOD VESSEL OPEN IN AN OPERATION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PATIENT IS REPORTED TO BE DOING WELL.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21783611 ↗InjuryApr 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A RECANALIZATION PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE HEAD END OF THE SUPPORT CATHETER WAS ALLEGEDLY FRACTURED IN THE BLOOD VESSEL. IT WAS FURTHER REPORTED THAT THE HEAD END WAS LEFT INSIDE THE SUPERFICIAL FEMORAL ARTERY VESSELS. REPORTEDLY, THE ARTERY VESSELS WERE FINALLY INCISED TO TAKE OUT THE HEAD END OF THE RESIDUAL SUPPORT CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. HOWEVER, THE CURRENT STATUS OF THE PATIENT UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21782964 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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