Severity
Moderate
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who h
Reported: April 8, 2020 Initiated: April 12, 2019 #Z-1637-2020 150 Units units
Bard Peripheral Vascular Inc issued this FDA Devices recall on April 8, 2020. Classified as Moderate severity (Class II). Approximately 150 Units units are affected. The recall was issued because: The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of ex…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1637-2020) was formally reported on April 8, 2020, with the manufacturer initiating the action on April 12, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Bard Peripheral Vascular Inc is listed as the recalling firm, operating out of Tempe, AZ. Federal records indicate 150 Units units are affected.
The documented reason for this recall is: The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another.… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of NY, TN, TX, FL, NC, GA, NH, MO, CA, SC, AL, IL, VA, IN. No US Gov. Consignees No OUS Consignees for the WavelinQ 4F EndoAVF System. However, a field action is in proces…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 6 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
150 Units
Related Recalls
6
6 from same agency
Product Description
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.
Reason for Recall
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.
Details
- Recalling Firm
- Bard Peripheral Vascular Inc
- Units Affected
- 150 Units
- Distribution
- US Nationwide distribution in the states of NY, TN, TX, FL, NC, GA, NH, MO, CA, SC, AL, IL, VA, IN. No US Gov. Consignees No OUS Consignees for the WavelinQ 4F EndoAVF System. However, a field action is in process of being initiated for affected lot of an equivalent product sold outside the US (EverlinQ 4F EndoAVF System). The equivalent product is not approved or sold in the US.
- Location
- Tempe, AZ
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1637-2020 |
| Date reported | April 8, 2020 |
| Date initiated | April 12, 2019 |
| Recalling firm | Bard Peripheral Vascular Inc |
| Units affected | 150 Units |
| Distribution | US Nationwide distribution in the states of NY, TN, TX, FL, NC, GA, NH, MO, CA, SC, AL, IL, VA, IN. No US Gov. Consignees No OUS Consignees for the WavelinQ 4F EndoAVF System. However, a field action is in process of being initiated… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Mfr. Bard Peripheral Vascular, Inc., Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 - Product Usage: The WavelinQ 4F EndoAVF System in indicated for the creation of an arteriovenous fistula (AVF) using concomitant ulnar artery and ulnar vein or concomitant radial artery and radial vein in patients with minimum artery and vein diameters of 2.0 mm at the fistula creation site who have chronic kidney disease and need hemodialysis.. Recalled by Bard Peripheral Vascular Inc. Units affected: 150 Units.
Why was this product recalled? ▼
The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2020. Severity: Moderate. Recall number: Z-1637-2020.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of NY, TN, TX, FL, NC, GA, NH, MO, CA, SC, AL, IL, VA, IN. No US Gov. Consignees No OUS Consignees for the WavelinQ 4F EndoAVF System. However, a field action is in process of being initiated for affected lot of an equivalent product sold outside the US (EverlinQ 4F EndoAVF System). The equivalent product is not approved or sold in the US..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1637-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).