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DQOClass 2

Catheter, Intravascular, Diagnostic

FDA adverse event reports and recall history for catheter, intravascular, diagnostic (product code DQO), from the public MAUDE corpus and the live FDA recall database.

Total reports
20,283
Deaths
446
Injuries
7,596
Malfunctions
11,372

Reports per year

12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.

Recent recalls

  • 2026-09-23Open, ClassifiedProcess control

    Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M001314041 IMAGER II/5/BARNH/100/038 BX5; M001314051 IMAGER II/5/BERN/100/038 BX5; M001314061 IMAGER II/5/BERN/100/035 BX 5; M001314081 IMAGER II/5/BERN/40/038 BX5; M001314101 IMAGER II/5/BERN/65/038 BX5; M001314141 IMAGER II/5/H1/100/038 BX5; M001314151 IMAGER II/5/H1/100/035 BX 5; M001314301 IMAGER II/5/SIM1/65/038 BX5; M001314321 IMAGER II/5/SIM1/100/038 BX5; M001314341 IMAGER II/5/SIM2/100/038 BX5; M001314351 IMAGER II/5/SIM2/100/035 BX 5; M001314361 IMAGER II/5/SIM3/100/038 BX5; M001314521 IMAGER II/5/CHGB/65/038 BX5; M001314581 IMAGER II/5/CONTRA 2/65/038 BX5; M001314621 IMAGER II/5/C1/65/038 BX5; M001314661 00AGER II/5/C2/65/038 BX5; M001314671 IMAGER II/5/C2/65/035 BX 5; M001314761 IMAGER II/5/MIK/65/038 BX5; M001314771 IMAGER II/5/MIK/65/035 BX 5; M001314821 IMAGER II/5/SHK1.0/65/038 BX5; M001314861 IMAGER II/5/RC2/65/038 BX5; M001314881 IMAGER II/5/RDC/65/038 BX5

    Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.

  • 2026-05-01Open, ClassifiedUnder Investigation by firm

    Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use in angiographic procedures are available in a variety of French sizes, endhole sizes, lengths, materials and designs (e.g., polyethylene or nylon, non-braided or braided with 1:1 torque). The choice of catheter material for different angiographic procedures should be based on the physician s experience.

    Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

  • 2026-05-01Open, ClassifiedUnder Investigation by firm

    Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

    Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

  • 2026-05-01Open, ClassifiedUnder Investigation by firm

    Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213 NR5.0-35-100-P-10S-0-CSC-20 G31214 NR5.0-35-100-P-10S-PIG-CSC-20 G31216 NR5.0-35-70-P-10S-VCF-CSC-20 G31220 NR5.0-35-100-P-10S-VCF-CSC-20 G31221 Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).

    Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.

  • 2026-04-17Open, ClassifiedNonconforming Material/Component

    Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  • 2026-04-17Open, ClassifiedNonconforming Material/Component

    Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  • 2026-04-17Open, ClassifiedNonconforming Material/Component

    Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 038 NB 6SH; Catalog No.: 10714001; Product/UPN No.: H787107140015 (Box), H787107140010 (Pouch); Box Quantity: 10 pouches;

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  • 2026-04-17Open, ClassifiedNonconforming Material/Component

    Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 65CM 038 NB 10SH; Catalog No.: 10714002; Product/UPN No.: H787107140025 (Box), H787107140020 (Pouch); Box Quantity: 10 pouches;

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  • 2026-04-17Open, ClassifiedNonconforming Material/Component

    Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouches;

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  • 2026-04-17Open, ClassifiedNonconforming Material/Component

    Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches;

    The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

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