MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CROSSER RECANALIZATION SYSTEM

Catalog Number	BDRECANSYSTEM
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the serial number for the device was provided, a review of the device history records is currently being performed.The device been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.Section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that there are no alleged issues with this bdrecansystem.This device is being returned to service center to get the latest software version update.There is no patient involvement.During evaluation, it was identified that the bdrecansystem's product label was missing.The 6-32 x 1/4 pan head screw is attached to the device in a ziploc bag, and the pem nut is screwed onto the pan head screw.The cable tie holder that holds the pump cable ferrite bead is loose from the double-sided tape.The back plate does not have pem nuts.The power entry plate pem nut is dislodged and threaded onto the pan head screw.
Event or Problem Description
It was reported that there are no alleged issues with this bdrecansystem.This device is being returned to service center to get the latest software version update.There is no patient involvement.During evaluation, it was identified that the bdrecansystem's product label was missing.The 6-32 x 1/4 pan head screw is attached to the device in a ziploc bag, and the pem nut is screwed onto the pan head screw.The cable tie holder that holds the pump cable ferrite bead is loose from the double-sided tape.The back plate does not have pem nuts.The power entry plate pem nut is dislodged and threaded onto the pan head screw.
Additional Manufacturer Narrative
H11: manufacturing review: a dhr and manufacturing review was not required as the event was determined to be expected, and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the bd recanalization system serial number (b)(6) was received at the bd-bard global service & repair.The bd recanalization system was visually inspected upon receipt and was found to be damaged.The product label was missing.One photo of the generator was provided.In the photo, the rear view of the console is visualized.The pole clamp, power switch and power entry was visible in the image.A small zip lock cover was placed above it with a screw inside, and no label information is available in the provided image.No other anomalies were identified.Therefore, the investigation is determined to be confirmed for the identified product label is missing issue.The root cause for identified product label is missing issue could not be determined based on the provided information.Labeling review: the labeling/packaging review was not required as the reported event is not associated with a labeling, packaging, or use related issue.G3, h6 (method, result, conclusion), h8.Section a through f: the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: CROSSER RECANALIZATION SYSTEM
• Common Device Name: RECANALIZATION SYSTEM
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24016868
• Report Number: 2020394-2025-02356
• Device Sequence Number: 10591238
• Product Code: PDU
• UDI-Device Identifier: 00801741202421
• UDI-Public: (01)00801741202421
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BDRECANSYSTEM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown